Status:
COMPLETED
Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
Lead Sponsor:
Johnson & Johnson Surgical Vision, Inc.
Conditions:
Cataract
Corneal Astigmatism
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.
Eligibility Criteria
Inclusion
- be at least 22 years old
- have cataracts in both eyes
- have a certain degree of astigmatism in at least one eye
- sign the written informed consent
- be willing and able to comply with examination procedures
- understand, read and write English to complete informed consent and questionnaires
- be available for study follow-up visits
- Both eyes must qualify to be eligible to participate in the study
Exclusion
- Currently participating in any other clinical study or have participated in a clinical study during the last 30 days
- Have a certain disease/illness such as poorly-controlled diabetes
- Have certain ocular conditions such as uncontrolled glaucoma
- Taking medication that may affect subject vision
- Have irregular corneal astigmatism
- Pregnant, plan to become pregnant during the study, or is breastfeeding
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2022
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT03791619
Start Date
December 13 2018
End Date
August 8 2022
Last Update
August 29 2023
Active Locations (23)
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1
Empire Eye & Laser Center
Bakersfield, California, United States, 93309
2
Southern California Eye Physicians & Associates
Long Beach, California, United States, 90805
3
Santa Monica Eye Medical Group
Santa Monica, California, United States, 90404
4
Wolstan & Goldberg Eye Associates
Torrance, California, United States, 90505